Study of Integrating Antiretroviral Therapy With Methadone Treatment for People Who Inject Drugs

HIV Clinical Trial

— IMAT  

Official title:

Reducing Failure-to-Initiate ART Among People Who Inject Drugs: the IMAT Strategy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02167425
• Other study ID #: IMAT-01
• Secondary ID: R34DA037787
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 17, 2014
• Last updated: November 19, 2015
• Start date: February 2015
• Est. completion date: March 2017

Study information

• Verified date: November 2015
• Source: Pangaea Global AIDS Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardTanzania: National Institute for Medical Research
• Study type: Observational

Clinical Trial Summary

To improve ART initiation among people who inject drugs, the investigators propose to develop and pilot a multi-component Integrated Methadone and Antiretroviral Therapy strategy (IMAT) in Dar es Salaam, Tanzania. In doing so, the investigators anticipate building a functional model of methadone and ART integration that improves the effectiveness and efficiency of service delivery.

Description:

The overarching goal of the proposed research is to develop and test an innovative implementation model (IMAT) for the effective integration of HIV care and treatment with methadone services in Dar es Salaam, Tanzania. The investigators will utilize the PRECEDE framework to inform the intervention to improve linkage of HIV-positive methadone patients to ART. This model suggests that strategies intended to improve health care delivery should consider a combination of three factors: 1) 'predisposing factors' - characteristics such as knowledge, attitudes, beliefs and motivation to change, 2) 'enabling factors' - characteristics that enable someone to act on their desired behavior and 3) 'reinforcing factors' - factors that encourage repetition or persistence of behavior. Therefore, our IMAT approach uses 1) targeted education and mentoring for providers that predispose them to timely ART initiation, 2) POC CD4 count platforms (PIMA, Alere) providing real-time screening and results that enable ART initiation and 3) an alerts and reminder dashboard (e.g., a summary of key indicators for improved decision making) for providers that reinforce ART initiation. Additionally, our approach will lay the foundation for developing implementation strategies for future point-of-care technologies such as viral load.

The study will combine a mixture of qualitative and quantitative methodologies to inform and evaluate the IMAT intervention.

A baseline qualitative study using in-depth interviews will be conducted among providers and methadone clients to understand predisposing, enabling and reinforcing factors related to integration of HIV care and treatment into the methadone clinic. Information gained from these qualitative assessments will inform and support the IMAT strategy. In addition, HIV-positive methadone clients will be randomly selected to complete a baseline cross-sectional survey to collect data on patient satisfaction, access to HIV care, current treatment navigation access, and HIV care literacy.

The investigators will assess the effectiveness of IMAT with a quasi-experimental pre-post cohort design and a pre-post cross-sectional survey to examine changes in patient- and provider-level outcomes after implementation of IMAT compared to before IMAT. In addition, The investigators will assess the feasibility and acceptability of the IMAT strategy using a post-implementation cross-sectional survey with a particular emphasis on satisfaction with services; a time motion study to understand the timeliness of care provision; and in-depth interviews with patients and providers to understand experiences with the IMAT strategy.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 800
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Methadone clients living with HIV but not linked to ART are the primary study population. Inclusion criteria for methadone initiation:

1. opioid dependence

2. positive urine screening for opiates.

Additional inclusion criteria include:

3. age = 18 years of age

4. HIV-positive. Individuals must also be willing to provide informed consent and be fluent in Kiswahili or English to participate in cross-sectional surveys and in-depth interviews

Exclusion Criteria:

We will exclude methadone clients from this study who have

1. received ART prior to methadone initiation

2. received a tuberculosis-positive diagnosis

3. women who are pregnant. The investigators have excluded clients who have received ART in the past as their inclusion would bias our study results. The investigators have also excluded patients with a tuberculosis diagnosis or women who are pregnant as they have a unique and urgent need for treatment and should be initiated onto ART regardless of their CD4 count

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV
• Opioid Dependence

Intervention

Other:
• IMAT
The IMAT intervention will combine three main strategies: point-of-care (POC) CD4 screening, provider training and mentoring, and an alerts and reminder dashboard. The POC CD4 platform will provide real-time clinical staging, enabling providers within the methadone clinic to screen HIV-infected patients for ART eligibility. Coupled with this technology, appropriate training and mentoring will predispose providers to effectively link patients to ART and integration of an alert and reminder dashboard will reinforce behavior change and strengthen processes.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Pangaea Global AIDS Foundation	Muhimbili University of Health and Allied Sciences, National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of patients satisfied with the quality of services provided		Up to three months post-intervention	No
Other	Percentage of patients satisfied with confidentiality at the facility		Up to three months post-intervention	No
Other	Percentage of patients satisfied with the time services are provided		Up to three months post-intervention	No
Other	Percentage of patients satisfied with waiting times		Up to three months post-intervention	No
Other	Average waiting time		Up to three months post-intervention	No
Other	Percentage of patients satisfied with visit times		Up to three months post-intervention	No
Other	Average visit time		Up to three months post-intervention	No
Other	Qualitative evaluation of feasibility and acceptability of the IMAT strategy		Up to three months post-intervention	No
Primary	Time to CD4 Screening	Number of days between positive HIV test and CD4 screening. Extracted from routine clinical and laboratory monitoring data.	Up to 36 months	No
Secondary	Provider Time to Ordering CD4 Screening	Collected via routine, programmatic data	Up to 36 months	No
Secondary	Percentage of clients that receive CD4 screening within 30 days of HIV-positive test	Collected via routine, programmatic data	Up to 36 months	No
Secondary	Percentage of eligible (CD4<350) clients that initiate ART within 30 days of CD4 screening	Collected via routine, programmatic data	Up to 36 months	No
Secondary	Percentage of clients on ART that receive at least 95% ART doses (i.e., adherence)	Collected via routine, programmatic data	Up to 36 months	No
Secondary	Percentage of patients receiving HIV treatment navigation counseling from provider	Collected via cross-sectional surveys pre- and post-intervention.	Three months pre-intervention and three months post-intervention	No
Secondary	Percentage of patients literate in CD4 screening process	Collected via cross-sectional surveys pre- and post-intervention.	Three months pre-intervention and three months post-intervention	No
Secondary	Percentage of patients literate in ART Initiation process	Collected via cross-sectional surveys pre- and post-intervention.	Three months pre-intervention and three months post-intervention	No
Secondary	Time to ART Initiation	Number of Days between receiving a qualifying CD4 count and first dose of ART. Extracted from routine clinical and laboratory monitoring data.	Up to 36 months	No